Pulmonary Healthy ControlsNCT02826239
Evaluation of Postural Effects on Multiple-breath-washout Derived Lung Function Parameters
An observational study of Pulmonary Healthy Controls and Pulmonary Disease, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
The investigators aim to evaluated the effect of postural changes on novel lung function parameters derived from multiple-breath-washout. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Healthy Controls, Pulmonary Disease
- What is being tested?
- multiple breath washout test (MBW)
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2016to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with and without known pulmonary disease
Who may be able to join
- patients with and without known pulmonary disease
Who cannot join
- pregnancy
- inability to participate
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsmedizin Mannheim
Mannheim, 68167
Frederik Trinkmann, Dr., +496213833879, frederik.trinkmann@umm.de
Frederik Trinkmann, Dr.
About this study
The investigators aim to evaluated the effect of postural changes on novel lung function parameters derived from multiple-breath-washout.
- Conditions
- Pulmonary Healthy Controls, Pulmonary Disease
- Being tested
- multiple breath washout test (MBW)
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple breath washout test (MBW)Device
measured in upright and supine position
| Study group | Role | What they receive |
|---|---|---|
| pulmonary healthy controls | patients without known pulmonary disease Receives: Device: multiple breath washout test (MBW) | |
| pulmonary disease | patients with known or suspected pulmonary disease Receives: Device: multiple breath washout test (MBW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of lung clearance index (LCI) as determined by multiple breath washout
Measured: 60 minutes
Secondary outcomes (1)
repeatability of lung clearance index (LCI)
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Healthy ControlsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826239
- Sponsor's protocol ID
- MBW-posture
- Status last verified
- Mar 2020
- First submitted
- 30 Jun 2016
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postural Effects on Multiple-breath-washout Derived Lung Function Parameters
- ClinicalTrials.gov ID
- NCT02826239
- Acronym / sponsor ID
- MBW-posture
- Conditions
- Pulmonary Healthy Controls, Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to evaluated the effect of postural changes on novel lung function parameters derived from multiple-breath-washout.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulmonary healthy controls | – | Device: multiple breath washout test (MBW)patients without known pulmonary disease |
| pulmonary disease | – | Device: multiple breath washout test (MBW)patients with known or suspected pulmonary disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with and without known pulmonary disease
Key inclusion criteria (1 listed)
- patients with and without known pulmonary disease
Key exclusion criteria (2 listed)
- pregnancy
- inability to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multiple breath washout test (MBW)measured in upright and supine position | Device | pulmonary disease, pulmonary healthy controls |
Primary outcome
change of lung clearance index (LCI) as determined by multiple breath washout
Time frame: 60 minutes
1 secondary outcome
repeatability of lung clearance index (LCI)
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Healthy Controls and Pulmonary Disease, run by Universitätsmedizin Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frederik Trinkmann, Dr. (+496213833879, frederik.trinkmann@umm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of lung clearance index (LCI) as determined by multiple breath washout (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.